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Mindful Meditation for Epidural Catheter Placement

Primary Purpose

Anxiety, Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
10 minute mindful meditation recording
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients are eligible for enrollment if they are greater than 18 years of age, admitted for vaginal delivery, anticipating epidural analgesia, and report a numerical pain scale rating of 3 or less at the time of enrollment.

Exclusion Criteria:

  • Do not speak English or admitted for cesarean delivery will be excluded from the study

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Neutral Content

Mindful Meditation

Arm Description

Participants will listen to a 10 minute neutral content recording just prior to epidural catheter placement.

Participants will listen to a 10 minute mindful meditation recording just prior to epidural catheter placement.

Outcomes

Primary Outcome Measures

Anxiety level after epidural catheter placement
Level of anxiety on a numerical rating scale
Pain level after epidural catheter placement
Level of pain on a numerical rating scale

Secondary Outcome Measures

Provider satisfaction level after epidural catheter placement
Anesthesia provider placing the epidural catheter satisfaction with placement conditions on a numerical rating scale

Full Information

First Posted
December 21, 2020
Last Updated
March 3, 2022
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04687085
Brief Title
Mindful Meditation for Epidural Catheter Placement
Official Title
Effects of a Brief Mindful Meditation Intervention on Patient Anxiety and Satisfaction for Labor Epidural Catheter Placement: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 21, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Given the high prevalence of neuraxial analgesia use during labor and the anxiety associated with these procedures, a method to decrease this anxiety could benefit millions of laboring women each year. Mindfulness practice has been used by many groups to decrease anxiety during pregnancy with optimistic results. However, there has been no major study evaluating the role of mindfulness interventions on anxiety associated with neuraxial placement. The purpose of our study is to address this gap in knowledge.
Detailed Description
The primary objective of this study is to evaluate the effects of a brief mindful meditation intervention on anxiety and satisfaction regarding epidural catheter placement for laboring parturients.The investigators hypothesize that a brief mindful meditation intervention, consisting of a 10 minute auditory instructional practice, implemented before epidural catheter placement will: Decrease anxiety Increase satisfaction compared to a neutral 10 minute auditory recording control, in participants undergoing labor epidural catheter placement. The secondary objective of this study is to evaluate whether anesthesia providers experience a difference in satisfaction with labor epidural catheter placement in participants who listen to a brief mindful meditation intervention prior to epidural catheter placement. The investigators hypothesize that anesthesia providers placing labor epidural catheters in patients who listen to a brief mindful meditation intervention prior to labor epidural catheter placement will: 1. Experience an increase in satisfaction with labor epidural catheter placement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neutral Content
Arm Type
Placebo Comparator
Arm Description
Participants will listen to a 10 minute neutral content recording just prior to epidural catheter placement.
Arm Title
Mindful Meditation
Arm Type
Experimental
Arm Description
Participants will listen to a 10 minute mindful meditation recording just prior to epidural catheter placement.
Intervention Type
Other
Intervention Name(s)
10 minute mindful meditation recording
Intervention Description
10 minute mindful meditation recording
Primary Outcome Measure Information:
Title
Anxiety level after epidural catheter placement
Description
Level of anxiety on a numerical rating scale
Time Frame
Measure 1 time, 10 minutes after epidural catheter placement
Title
Pain level after epidural catheter placement
Description
Level of pain on a numerical rating scale
Time Frame
Measure 1 time, 10 minutes after epidural catheter placement
Secondary Outcome Measure Information:
Title
Provider satisfaction level after epidural catheter placement
Description
Anesthesia provider placing the epidural catheter satisfaction with placement conditions on a numerical rating scale
Time Frame
Measure 1 time, 10 minutes after epidural catheter placement

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnancy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients are eligible for enrollment if they are greater than 18 years of age, admitted for vaginal delivery, anticipating epidural analgesia, and report a numerical pain scale rating of 3 or less at the time of enrollment. Exclusion Criteria: Do not speak English or admitted for cesarean delivery will be excluded from the study
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
To maintain privacy and confidentiality, patient data will be labeled with an alphanumeric code, the key to the code will be kept in a secure location separate from other data forms and will only be accessible to the investigators.

Learn more about this trial

Mindful Meditation for Epidural Catheter Placement

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